Chronic Suppurative Otitis MediaNCT06160505
Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media
An observational study of Chronic Suppurative Otitis Media, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
Trial summary
Chronic suppurative otitis media (CSOM) is characterized by intermittent or continuous otorrhea lasting for longer than 6 weeks. Most cases can be treated conservatively using antibiotic drops and oral antibiotics. However, some cases will not respond to conservative treatment and demonstrate persistant discharge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Suppurative Otitis Media
- What is being tested?
- S53P4 Bioactive glass
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients that underwent canal wall up or canal wall down mastoidectomy between 2010 and 2022 will be evaluated. Only cases that full-fill the in- and exclusion criteria will be selected. Patients will be stratified for whether they received mastoid obliteration or not.
Who may be able to join
- Suffering from CSOM, as indicated by otorrhea as main complaint preoperatively
- At least one year of follow-up, in order to asses the primary outcome
- Opacification of the mastoid air cells on preoperative CT-scans, as indication for mastoid involvement
- Canal wall up or canal wall down mastoidectomy
- Operated between 2010 and 2022
Who cannot join
- Patients suffering from middle ear cholesteatoma
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Diakonessenhuis
Utrecht, 3582KE
Leij-Halfwerk, Msc, Ir, 088-250 6172, Wetenschapsbureau@diakhuis.nl
J.J. Quak, MD, PhD
About this study
Official title: Mastoidectomy Followed by Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media: a Retrospective Comparative Study
Chronic suppurative otitis media (CSOM) is characterized by intermittent or continuous otorrhea lasting for longer than 6 weeks. Most cases can be treated conservatively using antibiotic drops and oral antibiotics. However, some cases will not respond to conservative treatment and demonstrate persistant discharge. In these cases, especially if a CT-scan shows opacification of the mastoid air cells, a mastoidectomy can be considered as treatment modality. In recent years, obliteration of the mastoid cavity following mastoidectomy is gaining popularity. However, the effectiveness of obliterating the mastoid in comparison to mastoidectomy alone is uncertain for CSOM. In this retrospective cohort study, our aim is to compare mastoidectomy to mastoidectomy + mastoid obliteration in a cohort of patients suffering from CSOM with mastoid involvement. The hypothesis is that obliterating the mastoid cavity will result in a higher frequency of dry ears and in a lower frequency of revision surgeries.
- Conditions
- Chronic Suppurative Otitis Media
- Being tested
- S53P4 Bioactive glass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S53P4 Bioactive glassDevice
Following mastoidectomy, the mastoid cavity, and if the ossicular chain has been removed the epitympanum as well, are obliterated using S53P4 bioactive glass. The bioactive glass is mixed with saline and administered to the cavity, ensuring a tight fit.
| Study group | Role | What they receive |
|---|---|---|
| Patients that underwent mastoidectomy alone | This is the control group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy for CSOM without mastoid obliteration | |
| Patients that underwent mastoidectomy + mastoid obliteration | This is the intervention group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy for CSOM followed by obliteration of the mastoid cavity using S53P4 bioactive glass Receives: Device: S53P4 Bioactive glass |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with a dry ear at one-year postoperatively
The number of cases that have a dry ear at the one-year postoperative out-patient visit. A dry ear is defined as Merchant grade 0 or 1 (No otorrhea or less than one period of otorrhea in the last three months, respectively). A wet ear, thus suffering from otorrhea, is defined as merchant grade 2 or 3 (intermittent more than once in last three months or continuous discharge, respectively). We compare the obliteration cohort to the non-obliteration cohort.
Measured: At 1-year postoperatively
Secondary outcomes (3)
The number of cases with perforations of the tympanic membrane during follow-up
The number of cases that will develop a perforation of the tympanic membrane during follow-up
We compare the obliteration cohort to the non-obliteration cohort.
Measured: Measured at 1-year postoperatively and 3-years postoperatively
The difference in air conduction postoperatively
The differences in air conduction postoperatively, as measured in the first audiometry postoperatively in decibel.
We compare the obliteration cohort to the non-obliteration cohort.
Measured: First audiometry postoperatively, which is made at 6 months postoperatively
The number of cases which require revision surgery during follow-up
The number of cases which require revision surgery during follow-up, for either recurrent CSOM and other indications
We compare the obliteration cohort to the non-obliteration cohort.
Measured: Measured at 3-years and 5-years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Oct 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Suppurative Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diakonessenhuis, Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J.J. Quak, MD, PhD, Principal investigator, Diakonessenhuis, Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160505
- Sponsor's protocol ID
- 16-004-2
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mastoidectomy Followed by Mastoid Obliteration Using S53P4 Bioactive Glass Versus Mastoidectomy Alone for Chronic Suppurative Otitis Media: a Retrospective Comparative Study
- ClinicalTrials.gov ID
- NCT06160505
- Acronym / sponsor ID
- 16-004-2
- Conditions
- Chronic Suppurative Otitis Media
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Diakonessenhuis, UtrechtUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic suppurative otitis media (CSOM) is characterized by intermittent or continuous otorrhea lasting for longer than 6 weeks. Most cases can be treated conservatively using antibiotic drops and oral antibiotics. However, some cases will not respond to conservative treatment and demonstrate persistant discharge. In these cases, especially if a CT-scan shows opacification of the mastoid air cells, a mastoidectomy can be considered as treatment modality. In recent years, obliteration of the mastoid cavity following mastoidectomy is gaining popularity. However, the effectiveness of obliterating the mastoid in comparison to mastoidectomy alone is uncertain for CSOM. In this retrospective cohort study, our aim is to compare mastoidectomy to mastoidectomy + mastoid obliteration in a cohort of patients suffering from CSOM with mastoid involvement. The hypothesis is that obliterating the mastoid cavity will result in a higher frequency of dry ears and in a lower frequency of revision surgeries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients that underwent mastoidectomy alone | – | –This is the control group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy for CSOM without mastoid obliteration |
| Patients that underwent mastoidectomy + mastoid obliteration | – | Device: S53P4 Bioactive glassThis is the intervention group, consisting of patients that have underwent either canal wall up or canal wall down mastoidectomy for CSOM followed by obliteration of the mastoid cavity using S53P4 bioactive glass |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients that underwent canal wall up or canal wall down mastoidectomy between 2010 and 2022 will be evaluated. Only cases that full-fill the in- and exclusion criteria will be selected. Patients will be stratified for whether they received mastoid obliteration or not.
Key inclusion criteria (5 listed)
- Suffering from CSOM, as indicated by otorrhea as main complaint preoperatively
- At least one year of follow-up, in order to asses the primary outcome
- Opacification of the mastoid air cells on preoperative CT-scans, as indication for mastoid involvement
- Canal wall up or canal wall down mastoidectomy
- Operated between 2010 and 2022
Key exclusion criteria (1 listed)
- Patients suffering from middle ear cholesteatoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S53P4 Bioactive glassFollowing mastoidectomy, the mastoid cavity, and if the ossicular chain has been removed the epitympanum as well, are obliterated using S53P4 bioactive glass. The bioactive glass is mixed with saline and administered to the cavity, ensuring a tight fit. | Device | Patients that underwent mastoidectomy + mastoid obliteration |
Primary outcome
The number of patients with a dry ear at one-year postoperatively
Time frame: At 1-year postoperatively
The number of cases that have a dry ear at the one-year postoperative out-patient visit. A dry ear is defined as Merchant grade 0 or 1 (No otorrhea or less than one period of otorrhea in the last three months, respectively). A wet ear, thus suffering from otorrhea, is defined as merchant grade 2 or 3 (intermittent more than once in last three months or continuous discharge, respectively). We compare the obliteration cohort to the non-obliteration cohort.
3 secondary outcomes
The number of cases with perforations of the tympanic membrane during follow-up
Time frame: Measured at 1-year postoperatively and 3-years postoperatively
The difference in air conduction postoperatively
Time frame: First audiometry postoperatively, which is made at 6 months postoperatively
The number of cases which require revision surgery during follow-up
Time frame: Measured at 3-years and 5-years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J.J. Quak, MD, PhD principal investigator
Diakonessenhuis, Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Suppurative Otitis Media, run by Diakonessenhuis, Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leij-Halfwerk, Msc, Ir (0882506172, Wetenschapsbureau@diakhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with a dry ear at one-year postoperatively (time frame: At 1-year postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.